Job Information
Insmed Inc. Executive Director, Clinical Development in Bridgewater, New Jersey
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview The role will be responsible for the oversight of the strategic clinical development plans and successful conduct and execution of the TPIP clinical development program in pulmonary hypertension-related indications in mid-to-late stage development. In addition, this role will be responsible for strategic direction of clinical aspects of engagements with health authorities related to registration programs and filings. The individual will articulate the project goals, strategy and the underlying science and clinical need to internal and external audiences with clarity and credibility. Responsibilities * Leads clinical development teams responsible for mid-to-late stage development of TPIP. * Leads the Clinical Program Team (CPT) to effectively make decisions and handle conflict and change. * Responsible for maintaining a high degree of CPT effectiveness through collaboration, influence, and, as necessary, coaching and mentoring of cross-functional team members. * Representative to matrix Global Asset Team to ensure clinical program is represented and integrated into Global plans across functions. * Build strategic and coordinated clinical development plans which are aligned with business objectives and are differentiated from competitor products. * Leads and communicates the clinical development strategy at governance meetings, accountable for aligning with internal management and for communicating with external collaborators. * Responsible for all clinical aspects of project strategy. * Accountable for the delivery of projects partnering with other global development and related functions. Requirements and Qualifications: * MD/DO equivalent with preference for Cardiology or Pulmonary formal training. Will consider industry experiences in Pulmonary or Cardiology in drug development. * 10+ years in biotech of pharma with most in a global clinical development role. Combination drug/device development experience is a plus. * Experience with filing original NDA or BLA required with additional sNDA or sBLA experience strongly preferred. Experience with J-NDA a plus. * Prefer experience in FDA advisory committee, or CHMP Scientific Advisory Group, or CHMP Oral Explanation experiences. * Previous direct people management experience required. * Experience working in matrix global development team, e.g. GPT, required.#LI-MM1 Salary Range $320,000 - $384,667 a year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: * Flexible approach to where and how we work, regionally based * Competitive compensation package including bonus * Stock options and RSU awards * Employee Stock Purchase Plan (ESPP) * Flexible Vacation Policy * Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS: * 401(k) plan with company match * MedTo view the full job description, click here>